Liver TransplantationOLTNCT00682110
Hemodynamic Measurements During Liver Transplantation
An observational study of Liver Transplantation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 subjects will be enrolled in this observational study in the Liver Transplant Group; 10 patients in the Other Surgery Control Group for a total of 30 subjects. Patients will be recruited from the Operating Room schedule. Written, informed consent will be obtained from each subject prior to surgery. All participants will be informed that they may decline to participate in, or withdraw from, the study at any time.
Who may be able to join
- Patients over 18 years of age
- Scheduled for liver transplantation
- Patient undergoing vascular surgery where invasive arterial pressure is indicated (control subjects)
Who cannot join
- We will exclude patients taking lithium based medication
- Patients who weigh less than 40 kg; AND
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Comparing Different Methods For Measurement of Cardiac Output During Orthotopic Liver Transplantation
The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.
Read the detailed description
Pulmonary artery catheter (PAC)is considered the gold standard in monitoring of heart function during orthotopic liver transplantation (OLT). Placement of PAC is very invasive (it passes thorough the heart chambers and into the pulmonary artery) and its benefits on the outcomes have not been proven. This study compares two newer FDA approved much less invasive devices to the PAC. The two new devices assess the heart function based either on the peripheral arterial waveform alone (Vigileo, Edwards Lifesciences)or the combination of peripheral arterial waveform and chemical indicator dilution (LiDCO, Cambridge, UK).
- Conditions
- Liver Transplantation
- Keywords
- End-stage liver disease, Hemodynamic measurements, Hyperdynamic circulation, Pulmonary artery catheter, Cardiac output
- Medical subject headings
- End Stage Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO
Measured: Specific phases of liver transplantation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Ivan Kangrga, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682110
- Sponsor's protocol ID
- 07-0042
- Acronym
- OLT
- Status last verified
- Mar 2010
- First submitted
- 16 May 2008
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Vannucci A, Burykin A, Krejci V, Peck T, Buchman TG, Kangrga IM. Postreperfusion cardiac arrest and resuscitation during orthotopic liver transplantation: dynamic visualization and analysis of physiologic recordings. Shock. 2012 Jan;37(1):34-8. doi: 10.1097/SHK.0b013e318239b128.
PubMed 22089184Krejci V, Vannucci A, Abbas A, Chapman W, Kangrga IM. Comparison of calibrated and uncalibrated arterial pressure-based cardiac output monitors during orthotopic liver transplantation. Liver Transpl. 2010 Jun;16(6):773-82. doi: 10.1002/lt.22056.
PubMed 20517912Vannucci A, Krejci V, Kangrga I. Performance of Vigileo and LiDCOplus cardiac output monitors during a prolonged cardiac arrest and resuscitation. Eur J Anaesthesiol. 2009 Oct;26(10):885-7. doi: 10.1097/EJA.0b013e32832fa5db. No abstract available.
PubMed 19606043
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Methods For Measurement of Cardiac Output During Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT00682110
- Acronym / sponsor ID
- OLT / 07-0042
- Conditions
- Liver Transplantation
- Keywords
- End-stage liver disease, Hemodynamic measurements, Hyperdynamic circulation, Pulmonary artery catheter, Cardiac output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.
Detailed description
Pulmonary artery catheter (PAC)is considered the gold standard in monitoring of heart function during orthotopic liver transplantation (OLT). Placement of PAC is very invasive (it passes thorough the heart chambers and into the pulmonary artery) and its benefits on the outcomes have not been proven. This study compares two newer FDA approved much less invasive devices to the PAC. The two new devices assess the heart function based either on the peripheral arterial waveform alone (Vigileo, Edwards Lifesciences)or the combination of peripheral arterial waveform and chemical indicator dilution (LiDCO, Cambridge, UK).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 subjects will be enrolled in this observational study in the Liver Transplant Group; 10 patients in the Other Surgery Control Group for a total of 30 subjects. Patients will be recruited from the Operating Room schedule. Written, informed consent will be obtained from each subject prior to surgery. All participants will be informed that they may decline to participate in, or withdraw from, the study at any time.
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Scheduled for liver transplantation
- Patient undergoing vascular surgery where invasive arterial pressure is indicated (control subjects)
Key exclusion criteria (3 listed)
- We will exclude patients taking lithium based medication
- Patients who weigh less than 40 kg; AND
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO
Time frame: Specific phases of liver transplantation surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2010.
- Derived from this study: PubMed 22089184Vannucci A, Burykin A, Krejci V, Peck T, Buchman TG, Kangrga IM. Postreperfusion cardiac arrest and resuscitation during orthotopic liver transplantation: dynamic visualization and analysis of physiologic recordings. Shock. 2012 Jan;37(1):34-8. doi: 10.1097/SHK.0b013e318239b128.
- Derived from this study: PubMed 20517912Krejci V, Vannucci A, Abbas A, Chapman W, Kangrga IM. Comparison of calibrated and uncalibrated arterial pressure-based cardiac output monitors during orthotopic liver transplantation. Liver Transpl. 2010 Jun;16(6):773-82. doi: 10.1002/lt.22056.
- Derived from this study: PubMed 19606043Vannucci A, Krejci V, Kangrga I. Performance of Vigileo and LiDCOplus cardiac output monitors during a prolonged cardiac arrest and resuscitation. Eur J Anaesthesiol. 2009 Oct;26(10):885-7. doi: 10.1097/EJA.0b013e32832fa5db. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Kangrga, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO (time frame: Specific phases of liver transplantation surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00682110, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2010; AzTrials last refreshed its copy on 6 Nov 2026.